Stem Cell Therapy Market Assessment, By Type [Allogeneic Stem Cell Therapy, Autologous Stem Cell Therapy], By Cell Source [Adipose Tissue, Bone Marrow, Placental/Umbilical Cord Cells, Other Sources], By Therapeutic Area [Oncology, Cardiovascular Disorders

Stem Cell Therapy Market Assessment, By Type [Allogeneic Stem Cell Therapy, Autologous Stem Cell Therapy], By Cell Source [Adipose Tissue, Bone Marrow, Placental/Umbilical Cord Cells, Other Sources], By Therapeutic Area [Oncology, Cardiovascular Disorders, Neurodegenerative Disorders, Orthopedics, Other Applications], By End-user [Hospitals, Ambulatory Surgical Centers, Research Centers, Others], By Region, Opportunities and Forecast, 2017-2031F

Global stem cell therapy market is projected to witness a CAGR of 15.75% during the forecast period 2024-2031, growing from USD 302.82 million in 2023 to USD 975.78 million in 2031. The stem cell therapy market is rapidly flourishing and has shown tremendous growth in terms of revenue and infrastructural growth in recent years. The market is expected to keep growing at a stronger pace owing to growing biotechnology research.

Stem cell therapy is a type of regenerative medicine approach involving the use of stem cells to promote the response against specific diseases and injured or dysfunctional tissues. The market is mainly influenced by factors like growing demand for regenerative medicine, the blooming biotechnology research sector, and investor’s traction to support the development of novel therapies. Regulatory approvals play a very crucial role in stem cell therapy market growth, as new approvals open more opportunities for other market players and motivate research to be directed in a certain direction. At present, the United States Food and Drug Administration (USFDA) only allows stem cell therapies based on hematopoietic (or blood) stem cell transplantation. Similarly, the European Medicines Agency (EMA) also imposes strict regulations on the approval of stem cell-based therapies and considers them under EU advanced therapy legislation, 2007.

As stem cell modification is the root of stem cell therapies, there are a significant number of ethical concerns, that pose a major threat to the growth and adoption of stem cell therapies. High prices of these therapies due to lots of capital and time investment also act as a challenge in this market. Despite all the challenges, the market for stem cell therapies has grown significantly and is expected to keep growing during the forecast period. Recent regulatory approvals gave a thrust to the market expansion. For instance, in December 2023, the European Medicines Agency (EMA) recommended the approval of the first medicine that uses CRISPR/Cas9, a cutting-edge gene-editing technology. The medicine, called Casgevy (exagamglogene autotemcel), is intended for treating transfusion-dependent beta-thalassemia and severe sickle cell disease in patients 12 years and older. This treatment is suitable for individuals for whom hematopoietic stem cell transplantation is appropriate and a suitable donor is not available.

Technological Advances and Innovative Research Drive Market Growth

Stem cell therapy was first introduced in its primitive form in 1956, and since then, it has witnessed several technological advancements. In recent times, technical advancements like rapid directed differentiation through genetic reprogramming in stem cells advances in the extracellular matrix, culture media, growth factors, dissociation reagents, and cryopreservation, automation, and robotic technologies, utilization of stem cell therapies for a wide variety of therapeutic applications like oncology, neurology, cardiovascular diseases, hemopoietic system disorders, etc. have contributed for the stem cell therapy market demands. Novel research outcomes in recent times show promising opportunities for the market.

For instance, in November 2023, the researchers from the Critical Analytics for Manufacturing Personalized Medicine (CAMP) Interdisciplinary Research Group (IRG) of Singapore-MIT Alliance for Research and Technology (SMART), MIT’s research enterprise in Singapore, developed a groundbreaking technology in collaboration with the Agency for Science, Technology and Research (ASTAR) Bioprocessing Technology Institute (BTI) and National University Health System (NUHS). This technology can extract mesenchymal stem cells (MSCs) directly from pure bone marrow, also known as bone marrow aspirate (BMA), without dilution. Bone marrow aspirate is a crucial source of MSCs.

Rising Investors’ Interest and Government Support to Accelerate the Market Growth

Capital investment in a particular market, acts as a major driver. The biotechnological research market, like the stem cell therapy market, requires huge amounts of funding for product development and market launches. In recent years, several notable investment trends from the public and private sectors in the development of stem cell therapies have been noticed. Government support in the form of grants, subsidies, or direct investments promotes market expansion. Governments of several nations, like the United States, Canada, Kenya, India, etc., have invested significantly in stem cell research initiatives in recent years.

For instance, the Australian government invested around USD 101 million (AUD 150 million) for the Stem Cell Therapies Mission with a roadmap of 10 years. Similarly, investment initiatives from market leaders have also been reported. In December 2023, FUJIFILM Holding Corporation invested USD 200 million in two subsidiaries to significantly expand its global cell therapy contract development and manufacturing (CDMO) capabilities. This investment will enable FUJIFILM to support the expanding cell therapy market.

Oncology Segment Dominates the Global Stem Cell Therapy Market

The oncology therapeutic area is the most explored application of stem cell therapy due to its high success rate. The unique properties of different stem cell types make them well-suited for a variety of applications in cancer diagnosis, treatment, and supportive care. As these technologies advance, stem cell-based therapies are poised to play an increasingly important role in the fight against cancer. Recent regulatory approvals further strengthened the dominance of the oncology segment. For instance, in April 2023, the USFDA approved Omisirge (omidubicel-only), a significantly modified allogeneic (donor) cord blood-based cell therapy developed by Gamida Cell Inc. This therapy is designed to speed up the recovery of neutrophils (a subset of white blood cells) in the body and reduce the risk of infection. The product is meant to be used in adults and pediatric patients aged 12 years and older with blood cancers who are undergoing umbilical cord blood transplantation following a myeloablative conditioning regimen, which involves treatments such as radiation or chemotherapy.

Asia-Pacific Shows Rapid Growth in the Stem Cell Therapy Market

Asia-Pacific is home to the world’s fastest-growing economies like India, China, Japan, etc., which is also reflected in the stem cell therapy market growth trends within the region. Several reasons behind the faster growth rate of the market in Asia-Pacific include growing disease prevalence and subsequent rise in demand for regenerative medicines, favorable government policies, and support for biotechnology research. Rising medical tourism and economic efficiency further support the growth of the market. Enhanced investments in the region also act as a major driver.

For instance, in May 2023, United States-based StemCures announced that it would establish India's largest stem cell manufacturing laboratory in Hyderabad, Telangana, with a projected investment of USD 54 million. The plant aims to produce high-quality and cost-effective stem cell treatments for various serious medical conditions using cutting-edge technology and knowledge from the United States. The project is expected to create up to 150 jobs in two phases. StemCures is currently finalizing its stem cell line research and development at Aspire Bionest, University of Hyderabad, and preparing to initiate its Phase-1 manufacturing laboratory.

Future Market Scenario (2024-2031F)

The stem cell therapy market holds tremendous growth opportunities for the future; as the demand for regenerative medicine rises, automation in the production of stem cells, along with the inclusion of artificial intelligence and other technologies, will rise significantly. Currently, the process of stem cell therapy is manual, but several attempts are being made to automate the process through artificial intelligence and several other tools from physics. The prospective automation will be able to overcome two major challenges of stem cell therapy: safety and scalability. Notable market activities have been reported in recent times for this innovation. For instance, Cellino Biotech, Inc., an American company, has developed a system that combines stem cell biology, machine learning, and laser physics to automate the manufacturing of stem cells. The laser editing system removes unwanted cells and delivers cargo to individual cells. This automated, AI-enabled manufacturing process is crucial for producing large numbers of patient-specific cells with low batch-to-batch variability, which is needed for clinical trials and the commercialization of stem cell therapy.

Key Players Landscape and Outlook

Several market players like AstraZeneca PLC, JCR Pharmaceuticals Co., Ltd., Celgene Corporation, Janssen Global Services, LLC, Takeda Pharmaceutical Company Limited, Novo Nordisk A/S, BlueRock Therapeutics LP, Gilead Sciences, Inc., Vertex Pharmaceuticals Incorporated, Bristol-Myers Squibb Company, etc. are contributing to the stem cell therapy market through novel products, innovative researches, regulatory approvals, etc. The industry accumulates a number of players ranging from small start-ups to global giants like AstraZeneca. Various market tactics like mergers and acquisitions, collaborations, and other deals among market players indicate active market growth.

In April 2024, Century Therapeutics, Inc. expanded its clinical development of CNTY-101, a CD19-targeting Invariant Natural Killer (iNK) cell therapy, into additional autoimmune disease indications. The company secured a USD 60 million private placement to support this expansion and acquired Clade Therapeutics, a biotech company focused on Induced pluripotent stem cells (iPSC)-derived cell therapies. This deal strengthens Century's position in allogeneic, iPSC-derived cell therapy and brings in additional pipeline programs and technology, positioning Century as a leader in the cell therapy space.

In February 2024, STEMCELL Technologies Canada Inc., Canada's largest biotechnology company, acquired all assets of SQZ Biotechnologies Co, a Massachusetts-based biotech known for its cell therapy delivery technology called mechanoporation. This acquisition includes SQZ's portfolio of over 400 patents and trademarks, other intellectual property, proprietary equipment, and its head license with the Massachusetts Institute of Technology. This move will enable STEMCELL to exclusively commercialize the CellPore Transfection System and associated CellPore Transfection Kits for use in all markets, including clinical applications. STEMCELL aims to transform patient outcomes by making life-changing cell therapies widely and rapidly accessible.